BLUE LIZARD ACTIVE SPF 50 SUNSCREEN- octisalate and titanium dioxide and zinc oxide lotion

Blue Lizard Active SPF 50 Sunscreen by

Drug Labeling and Warnings

Blue Lizard Active SPF 50 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Crown Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octisalate 5%

Titanium Dioxide 5.36%

Zinc Oxide 10%

Purpose

Sunscreen

Uses

• Helps prevent sunburn and photodamage caused by UVA/UVB exposure
• Higher SPF gives more sunburn protection
• If used as directed with other sun protection measures (see Directions), decreases the risks of skin cancer and early skin aging caused by the sun

Warnings

When using this product Keep out of eyes. Rinse with water to remove

Stop use and ask doctor if Rash or irritation occurs

Do not use On damaged or broken skin If allergic to any ingredient

If swallowed, get medical help or contact a Poison Control Center

Directions

Shake well prior to use

Apply liberally to dry skin 15 minutes before sun exposure

For topical use only

Children under 6 months: ask a doctor

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 p.m.

Wear long-sleeved shirts, pants, hats, and sunglasses.

Reapply to dry skin: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours

Keep out of reach of children

Other Information

• Protect the product in this container from excessive heat and direct sun
• May stain some fabrics

Inactive Ingredients

Alumina, Aluminum Stearate, Beeswax, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Capylic/Capric Triglyceride, Caprylyl Glycol, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Diisopropyl Sebacate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Hexyl Laurate, Hydrogenated Castor Oil, Isostearyl Isostearate, L-Arginine, Methyl Glucose Dioleate, Methylpropanediol, Octyldodecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Phenoxyethanol, Phenylpropanol, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polyurethane-35, Propanediol, Purified Water, Sorbitan Oleate, Stearic Acid, Tocopheryl Acetate, Triethoxycaprylylsilane, Trimethylsiloxysilicate, VP Hexadecene Copolymer

Questions?

Visit www.bluelizardsunscreen.com or call 800.877.8869

Crown Laboratories, Inc., Johnson City, TN 37604

Blue Lizard Active 5oz Tube

BLUE LIZARD

AUSTRALIAN SUNSCREEN

50+

UVA/UVB PROTECTION

BROAD SPECTRUM

SPF 50+

TRAUSTED BY DERMATOLOGISTS FOR OVER 20 YEARS

ACTIVE

mineral-based sunscreen

combining mineral and chemical UV protectors

Smart Cap TECHNOLOGY

CAP CHANGES COLOR IN HARMFUL UV LIGHT

WATER RESISTANT (80 MINUTES)

Mineral-Based Sunscreen

Combining mineral and chemical UV protectors for water-resistant performance you can trust.

P11863.00

INGREDIENTS AND APPEARANCE

BLUE LIZARD ACTIVE SPF 50 SUNSCREEN 
octisalate and titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0316-2072
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	55.5 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	59.5 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	111 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALUMINUM OXIDE (UNII: LMI26O6933)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
YELLOW WAX (UNII: 2ZA36H0S2V)
ARGININE (UNII: 94ZLA3W45F)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PEG-7 HYDROGENATED CASTOR OIL (UNII: WE09129TH5)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPANEDIOL (UNII: 5965N8W85T)
WATER (UNII: 059QF0KO0R)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) (UNII: AG75W62QYU)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENYLPROPANOL (UNII: 0F897O3O4M)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
POLYURETHANE-35 (NOT MORE THAN 500 MPA.S AT 40%) (UNII: Q2LKX89BE0)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0316-2072-30	89 mL in 1 TUBE; Type 0: Not a Combination Product	05/01/2021
2	NDC: 0316-2072-50	259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2021
3	NDC: 0316-2072-45	148 mL in 1 TUBE; Type 0: Not a Combination Product	02/09/2021
4	NDC: 0316-2072-40	1 in 1 CARTON	02/24/2021
4		148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/09/2021

Labeler - Crown Laboratories (079035945)

Establishment
Name	Address	ID/FEI	Business Operations
Crown Laboratories		079035945	manufacture(0316-2072)